Trial Condition(s):
Multiple Sclerosis
EPID Multiple Sclerosis Pregnancy Study
Bayer Identifier:
18219
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult females in their childbearing ages. Little evidence is available regarding the association between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Therefore the four marketing holders of IFN-β are conducting a European-wide IFN-β pregnancy registry. Additionally, the Committee for Medicinal Products for Human Use (CHMP) has requested a study to enable identification of pregnancy outcomes in the MS population unexposed to IFN-β products for comparison with the ongoing European IFN-β Pregnancy Registry.
Inclusion Criteria
: - Women who have had a pregnancy with a recorded outcome consisting of an induced abortion, spontaneous abortion, ectopic pregnancy, or birth during the study period in FIN, SWE or NOR with the event being documented in the relevant databases.
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
2089
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Many locations Many locations, Finland | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Pregnancy outcomes in Multiple Sclerosis populations exposed and unexposed to interferon β – a register-based study in the Nordic countries
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
6
Primary Outcome
- Serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including presence of elective Termination of Pregnancy due to Foetal Anomaly (TOPFA), Major Congenital Anomaly (MCA) or stillbirthCohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDsTimeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Elective TOPFA for other reasons than IFN-β exposureCohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDsTimeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Elective termination for other reasonsthan IFN-β exposureCohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDsTimeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Stillbirth due to different regimes of IFN-β exposureCohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDsTimeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Live birth while different regimes of IFN-β exposureCohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDsTimeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- MCA due to different regimes of IFN-β exposureCohort 1: Exposure to IFN-β only Cohort 2: All patients with IFN-β exposure regardless of exposure to other MS Disease Modifying Drug (MSDMDs) Cohort 3: No exposure to any MSDMDs Cohort 4: All patients with no IFN-β exposure regardless of exposure to other MSDMDsTimeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Comparison of the prevalence of serious adverse pregnancy outcome due to different regimes of IFN-β exposure defined as a composite endpoint including elective TOPFA, MCA or stillbirth1) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)Timeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Comparison of the prevalence of elective termination for other reasons than due to different regimes of IFN-β exposure1) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)Timeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Comparison of the prevalence of stillbirth due to different regimes of IFN-β exposure1) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)Timeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Comparison of the prevalence of live birth due to different regimes of IFN-β exposure1) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)Timeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Comparison of the prevalence of MCA due to different regimes of IFN-β exposure1) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)Timeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Comparison of the prevalence of Elective TOPFA due to different regimes of IFN-β exposure1) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3) and 2) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4)Timeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Secondary Outcome
- Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposure1) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3), 2) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4) 3) Women with MS exposed to IFN-β regardless of exposure to other MSDMDs (cohort 2) vs. unexposed to any MSDMDs (cohort 3)Timeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Comparison of the prevalence of spontaneous abortions due to different regimes of IFN-β exposure1) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to any MSDMDs (cohort 3), 2) Women with MS exposed to IFN-β only (cohort 1) vs. unexposed to IFN-β regardless of exposure to other MSDMDs (cohort 4) 3) Women with MS exposed to IFN-β regardless of exposure to other MSDMDs (cohort 2) vs. unexposed to any MSDMDs (cohort 3)Timeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Prevalence of elective TOPFA stratified by specific patient characteristicsPatient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newbornTimeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Prevalence of stillbirth stratified by specific patient characteristicsPatient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newbornTimeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Prevalence of live birth stratified by specific patient characteristicsPatient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newbornTimeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Prevalence of MCA stratified by specific patient characteristicsPatient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newbornTimeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
- Comparison of the prevalence of ectopic pregnancies due to different regimes of IFN-β exposurePatient characteristics: country, year of pregnancy outcome, chronic diseases, exposure to any teratogenic medications, time since MS diagnosis, duration of MS treatment, maternal age, gestational age, weight of the newbornTimeframe: Retrospective Data analysis: MS patients data encompassing approximately 19 years
Additional Information
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